Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants (MESK-1)

A Retrospective Observational Medical Dossier-based Study to Assess Gastrointestinal Discomfort and Infections in Healthy Term Infants

A retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants

Study Overview

• Status: Active, not recruiting
• Conditions: Growth; Infection; Gastrointestinal Symptoms; Allergy Symptoms
• Intervention / Treatment: Other: Infants fed goat milk-based infant formula

Detailed Description

Gastrointestinal (GI) symptoms like regurgitation, unexplained crying and stool issues (diarrhoea or constipation) are common in young infants <4 months of age due to an immature gut epithelial barrier, immune system and microbiota, with studies indicating prevalences ranging from 25.9%-78%. This retrospective observational medical dossier-based study is designed to determine the occurrence of GI symptoms in healthy term formula-fed infants to confirm reported prevalence of mild GI symptoms by HCPs in Middle East (74%). As a secondary objective, the improvement of confirmed GI symptoms when switched before 4 months of age from a CMF to GMF will be determined. Based on the results of a previous study in infants with confirmed GI symptoms, it is expected that fewer GI symptoms will be scored in medical dossiers of infants after switching from CMF to GMF, with HM as a reference group. Other secondary objectives of this study are to explore differences between healthy term infants that were fed GMF compared to infants fed CMF or HM on immune related outcomes such as infections and allergies, medication use related to infections and/or gastrointestinal discomfort and/or allergies, number of clinic visits, adequate growth and reason of changing infant formula.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Saudi Arabia
  • Gizan, Saudi Arabia
    • Al Emies hospital
  • Jubail, Saudi Arabia
    • Mana GH Jubail
  • Medina, Saudi Arabia
    • AlAhmady Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 300 healthy term infants with medical dossiers covering the period of 0-12 months of age and at least 6 clinic visits.

Description

Inclusion Criteria:

• Either exclusively formula fed (GMF or CMF; consumption of HM ≤2 weeks is allowed for formula fed infants) OR exclusively breastfed before introduction of complementary feeding.
• Age 12-24 months of age to ensure collection of recent data.
• If required by local regulation or guidelines, written informed consent (ICF) from Investigator (or parent(s) and/or caregiver(s)* aged ≥18 years).
• Singleton, term infants (gestational age ≥ 37 weeks and ≤ 42 weeks).
• At least 6 reported visits to the doctor between 0-12 months of age.

Exclusion Criteria:

• Consumed hydrolysed infant formula or other specialty formulas.
• Any current or previous illnesses/conditions and/or known congenital diseases or malformations which could interfere with the study outcomes, as per Investigator's clinical judgement.
• Participation in any clinical trial during first year of life.
• For formula-fed infant, no switch in feeding type after 4 months of age is allowed.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Formula-fed infants; Formula-fed infants either goat milk-based infant formula or cow's milk-based infant formula	Other: Infants fed goat milk-based infant formula; Type of infant feeding during the age of 0-12 months; Other Names: Infants fed cow's milk based infant formula; Infants breastfed / human milk feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the occurrence of symptoms related to GI discomfort in formula-fed infants in the Gulf region	To determine the number of symptoms related to GI discomfort in formula-fed infants between 0-12 months of age	retrospective infants from 0 - 12 months of age

Collaborators and Investigators

• Sponsor: Ausnutria Hyproca B.V.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: growth; infant; retrospective; GI symptoms; medical dossier-based study; infection symptoms; allergy symptoms; type of feeding
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: P24-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No